Clarity Medical Systems Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1265-2014Class IIHalogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. GMarch 7, 2014
Z-1154-2014Class IIRetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; PleasJanuary 24, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K102859RETCAM 3 OPTHALMIC IMAGING SYSTEMApril 20, 2011
K090326RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMSNovember 25, 2009
K083771RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCPJanuary 30, 2009
K081858RETCAM 3 OPHTHALMIC IMAGING SYSTEMNovember 5, 2008